Wednesday, October 11, 2017 3:02:56 PM
Yea, the Good Results Were Phony (?)
So, Anavex didn’t test their drug on enough Alzheimer’s patients to determine to any degree if it worked?
Of course, for FDA authorization, the big Phase 3 study will have to be conducted, and favorable outcomes precisely documented. Statistical analysis. FDA doesn’t much approve drugs on the basis of stock investor perceptions.
Potential or current Anavex investors can presently see the matter in at least two ways.
Some, based upon the principles of biostatistics, solely, contend that there can be no way of knowing any useful safety or efficacy in the Phase 1 trial of just 25 to 31 Alzheimer’s patients. “Sample size” too small. Who could (would, or should) determine anything from those results?
Others, take cognizance of the facts that a) symptoms in all participants were either held at baseline (didn’t decline), or actually improved, and b) no other approved drug has shown these traits. Those holding to this view perceive that the chances of randomly including only 100% super responders as the cause of the good results are minute; that the real reason all trial participants maintained or improved their cognition was because Anavex 2-73, with its unique mechanism of action, actually does, as the company contends, restores neuron homeostasis, normalized nerve function.
This post is not intended to change or modify anyone’s personal perception of the matter. Merely, it’s posted for an interesting analysis of the eventual Phase 3 results.
Who will prove to have had it right from the start? The “No can tell, too small – stay out early” crowd? Or, the “Can’t be anything but good –- get in early” crowd?
Sample size of prior trials...
So, Anavex didn’t test their drug on enough Alzheimer’s patients to determine to any degree if it worked?
Of course, for FDA authorization, the big Phase 3 study will have to be conducted, and favorable outcomes precisely documented. Statistical analysis. FDA doesn’t much approve drugs on the basis of stock investor perceptions.
Potential or current Anavex investors can presently see the matter in at least two ways.
Some, based upon the principles of biostatistics, solely, contend that there can be no way of knowing any useful safety or efficacy in the Phase 1 trial of just 25 to 31 Alzheimer’s patients. “Sample size” too small. Who could (would, or should) determine anything from those results?
Others, take cognizance of the facts that a) symptoms in all participants were either held at baseline (didn’t decline), or actually improved, and b) no other approved drug has shown these traits. Those holding to this view perceive that the chances of randomly including only 100% super responders as the cause of the good results are minute; that the real reason all trial participants maintained or improved their cognition was because Anavex 2-73, with its unique mechanism of action, actually does, as the company contends, restores neuron homeostasis, normalized nerve function.
This post is not intended to change or modify anyone’s personal perception of the matter. Merely, it’s posted for an interesting analysis of the eventual Phase 3 results.
Who will prove to have had it right from the start? The “No can tell, too small – stay out early” crowd? Or, the “Can’t be anything but good –- get in early” crowd?
Recent AVXL News
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 05/01/2026 11:18:47 PM
- Anavex Life Sciences Highlights New Scientific Findings on Shared Biology Between Autism and Alzheimer’s Disease • GlobeNewswire Inc. • 04/14/2026 11:30:00 AM
- Anavex Life Sciences to Present at the 25th Annual Needham Virtual Healthcare Conference • GlobeNewswire Inc. • 04/07/2026 11:30:00 AM
- Anavex withdraws EU approval filing for Alzheimer’s therapy • IH Market News • 03/30/2026 12:39:26 PM
- Anavex Life Sciences Provides Comprehensive Regulatory Update • GlobeNewswire Inc. • 03/30/2026 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/25/2026 08:06:00 PM
- Anavex withdraws EU marketing application for Alzheimer’s therapy blarcamesine • IH Market News • 03/25/2026 02:06:58 PM
- Anavex Life Sciences Provides Update on Regulatory Review in the EU for Blarcamesine to Treat Early Alzheimer’s Disease • GlobeNewswire Inc. • 03/25/2026 11:30:00 AM
- Anavex Life Sciences Presents New Data from its AD-004 Phase IIb/III Trial at AD/PD 2026 Conference Demonstrating Consistent Correlation Between the Treatment Effect of Oral Blarcamesine and Preservation of Brain Volume in Early Alzheimer’s Disease • GlobeNewswire Inc. • 03/23/2026 11:30:00 AM
- New Scientific Findings Highlight Hypothesis of Autophagy Failure as a Precursor of Amyloid Beta and Tau Pathology in Alzheimer’s Disease • GlobeNewswire Inc. • 03/20/2026 11:30:00 AM
- Anavex Life Sciences Presents Significant Treatment Effects of Blarcamesine in New Advanced Alpha-Synuclein Model of Parkinson’s Disease at AD/PD 2026 Conference • GlobeNewswire Inc. • 03/17/2026 11:30:00 AM
- Anavex Life Sciences to Present at the Citizens Life Sciences Conference • GlobeNewswire Inc. • 03/03/2026 12:30:00 PM
- Anavex Life Sciences to Present at the 46th TD Cowen Annual Health Care Conference • GlobeNewswire Inc. • 02/25/2026 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/25/2026 11:07:01 AM
- Anavex Life Sciences Appoints Seasoned Healthcare Leader to Board of Directors • GlobeNewswire Inc. • 02/23/2026 12:30:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/09/2026 09:40:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/09/2026 12:31:17 PM
- Anavex Life Sciences Reports Fiscal 2026 First Quarter Financial Results and Provides Business Update • GlobeNewswire Inc. • 02/09/2026 12:30:00 PM
- Anavex Life Sciences to Announce Fiscal 2026 First Quarter Financial Results on Monday, February 9, 2026 • GlobeNewswire Inc. • 02/03/2026 12:30:00 PM
- Anavex Joins ACCESS-AD, a Major Initiative Funded by the European Commission, Through the Clinical Evaluation of Blarcamesine as Part of a Precision Medicine Approach in Alzheimer’s Disease • GlobeNewswire Inc. • 01/13/2026 12:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/09/2026 10:26:26 PM
- Edelson Lechtzin LLP Announces an Investigation of Anavex Life Sciences Corp. (NASDAQ: AVXL) and Encourages Investors with Substantial Losses Contact the Firm • PR Newswire (US) • 01/09/2026 01:13:00 AM
- Anavex Life Sciences Appoints Senior Vice President Global Head of Neurology • GlobeNewswire Inc. • 01/08/2026 12:30:00 PM
- Anavex Life Sciences Receives FDA Feedback on Alzheimer’s Disease Program • GlobeNewswire Inc. • 01/06/2026 12:30:00 PM
- Anavex Life Sciences Submitted Request for EMA to Re-Examine Its Opinion • GlobeNewswire Inc. • 12/18/2025 12:30:00 PM
